FOR SCRIPT ONLINE - compounding self assessment.docx - pharmacy ca 2025

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The document outlines the self-assessment requirements for pharmacies in California that compound drug preparations, as mandated by the California Code of Regulations. It details the compliance process, including timelines for assessments, recordkeeping, labeling, and quality assurance measures to ensure adherence to federal and state pharmacy laws. The primary goal is to promote compliance through self-examination and education among pharmacists-in-charge.
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Existing law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board.
Compounding pharmacies must use pharmaceutical-grade ingredients, made at an FDA-registered facility, when creating a compounded medication. While these medications are not subject to federal laws that regulate mass-produced drugs, compounding pharmacies in the U.S. are overseen by their state Board of Pharmacy.
Any pharmacy that provides medications that are not commercially available and prepares them onsite to meet your specific needs is a compounding pharmacy, explains Dr.
A Compounding Record (CR) is a document that records the preparation of a compounded medication. It is important to maintain compounding records to demonstrate compliance with USP standards.
The primary purpose of the self-assessment is to promote compliance through self-examination and education. The self-assessment must be completed in its entirety. It may be completed online, printed, initialed, signed, and readily available in the pharmacy.

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A pharmacy shall not compound sterile drug products for injection, administration into the eye, or inhalation unless the pharmacy has obtained a sterile compounding pharmacy license issued by the board. The licenses are renewed annually and are not transferrable.
Some compounded medications are made with OTC ingredients, so you may not need a prescription for those. This can depend on where the pharmacy is located, and if its allowed in your specific state. But if you want to submit them to your insurance, a prescription is always required.

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Self-Assessment Forms - California State Board of Pharmacy

The self-assessment forms must remain on-site at the facility. Only submit the form to the board if requested by board staff.

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MISSOURI PHARMACY PRACTICE GUIDE

Pharmacy Self-Assessment. Guide. Resources are also available for technicians patients that their prescription or medication order may be filled or compounded

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